BS EN ISO 23747:2009 PDF

Scope: This International Standard specifies requirements for peak expiratory flow meters (PEFMs) intended for the assessment of pulmonary function in spontaneously breathing humans. This International Standard covers all devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function device or as a stand-alone device. Planning and design of products applying to this International Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E. NOTE Additional aspects of environmental impact are addressed in ISO 14971.

BS EN ISO 23747:2009 Referenced Document

IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 14937 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices*， 2009-10-01 Update
ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

2015 BS EN ISO 23747:2015 Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
2009 BS EN ISO 23747:2009 Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans